U.S. patent application number 12/356835 was filed with the patent office on 2010-07-22 for needled cannula with filter device.
This patent application is currently assigned to ABBOTT CARDIOVASCULAR SYSTEMS INC.. Invention is credited to Gregory W. Chan.
Application Number | 20100185179 12/356835 |
Document ID | / |
Family ID | 42337531 |
Filed Date | 2010-07-22 |
United States Patent
Application |
20100185179 |
Kind Code |
A1 |
Chan; Gregory W. |
July 22, 2010 |
NEEDLED CANNULA WITH FILTER DEVICE
Abstract
An apparatus may include a cannula. The cannula may be operable
to be percutaneously advanced through a blood vessel. The cannula
may have a proximal end and a distal end. At least one needle may
be coupled to the distal end of the cannula. A filter device may be
coupled at a position proximal to the at least one needle. The
filter device may have a distal portion that is operable to have a
first diameter under a first condition and a second, different
diameter under a second condition. Methods of using such an
apparatus are also disclosed.
Inventors: |
Chan; Gregory W.; (San
Francisco, CA) |
Correspondence
Address: |
ABBOTT CARDIOVASCULAR SYSTEMS INC./BSTZ;BLAKELY SOKOLOFF TAYLOR & ZAFMAN
LLP
1279 OAKMEAD PARKWAY
SUNNYVALE
CA
94085-4040
US
|
Assignee: |
ABBOTT CARDIOVASCULAR SYSTEMS
INC.
Santa Clara
CA
|
Family ID: |
42337531 |
Appl. No.: |
12/356835 |
Filed: |
January 21, 2009 |
Current U.S.
Class: |
604/508 ;
604/272; 606/200 |
Current CPC
Class: |
A61B 17/3478 20130101;
A61F 2/013 20130101; A61F 2002/018 20130101; A61F 2230/0006
20130101; A61B 2017/320716 20130101; A61F 2230/0067 20130101; A61B
2217/007 20130101; A61F 2230/008 20130101; A61B 2090/064 20160201;
A61B 2217/005 20130101 |
Class at
Publication: |
604/508 ;
604/272; 606/200 |
International
Class: |
A61M 25/06 20060101
A61M025/06; A61M 1/00 20060101 A61M001/00 |
Claims
1. An apparatus comprising: a cannula to be percutaneously advanced
through a blood vessel, the cannula having a proximal end and a
distal end; at least one needle coupled to the distal end of the
cannula; and a filter device coupled at a position proximal to the
at least one needle, the filter device having a distal portion that
is operable to have a first diameter under a first condition and a
second, different diameter under a second condition.
2. The apparatus of claim 1, wherein the apparatus comprises an
intra-myocardial needle injection catheter, and wherein if the at
least one needle were positioned to inject a treatment agent into a
left ventricle of a heart, then the filter device would have a
position ranging from a carotid artery to papillary muscles that
are distal to an aortic valve.
3. The apparatus of claim 2, wherein the position of the filter
device would range from the carotid artery to leaflets of the
aortic valve.
4. The apparatus of claim 1, wherein the filter device comprises a
frame portion including a helical spring and a filter material
having a plurality of openings coupled to the frame portion, and
wherein the filter device has a generally tubular shape under the
second condition.
5. The apparatus of claim 4, wherein a distal portion of the frame
portion is coupled to the apparatus at a fixed position, and
further comprising a shaft having a proximal end and a distal end
that is coupled to a proximal portion of the frame portion.
6. The apparatus of claim 5, wherein the shaft comprises a plunger
that is operable to compress the helical spring, and wherein the
first and second conditions comprise different amounts of
compression of the helical spring.
7. The apparatus of claim 5, wherein the helical spring comprises a
torsion spring, wherein the shaft is operable to turn about the
cannula to twist the helical spring, and wherein the first and
second conditions comprise different amounts of twisting of the
helical spring.
8. The apparatus of claim 1, further comprising: at least one
aspiration port proximate the at least one needle; a lumen through
the cannula from the at least one aspiration port to a proximal
portion of the cannula to convey suction provided at the proximal
portion of the cannula to the at least one aspiration port.
9. The apparatus of claim 8, wherein the at least one aspiration
port comprises at least one aspiration port on a distal end face of
the cannula where the at least one needle is coupled.
10. The apparatus of claim 8, wherein the at least one aspiration
port comprises a plurality of aspiration ports distributed around
the at least one needle.
11. The apparatus of claim 10, wherein the plurality of aspiration
ports are distributed concentrically around the at least one needle
at a distal end face of the cannula where the at least one needle
is coupled.
12. The apparatus of claim 10, wherein the at least one aspiration
port comprises a plurality of aspiration ports distributed along a
distal segment of the cannula.
13. The apparatus of claim 8, wherein the at least one aspiration
port comprises an aspiration/flush port, and wherein the
aspiration/flush port is coupled with at least the lumen to
alternatively flow a fluid outwardly through the aspiration/flush
port and to draw a material inwardly through the aspiration/flush
port.
14. The apparatus of claim 8, further comprising at least one
sensor to sense at least one of pressure of a fluid in the lumen
and flow rate of the fluid in the lumen.
15. The apparatus of claim 1, further comprising: at least one
aspiration port through an exterior surface of the filter device;
and a lumen from a proximal portion of the apparatus and in fluid
communication with the at least one aspiration port to convey
suction provided at the proximal portion of the apparatus to the at
least one aspiration port.
16. The apparatus of claim 1, wherein the filter device is coupled
to an exterior surface of the cannula.
17. The apparatus of claim 1, further comprising a second cannula
through which the cannula is inserted, and wherein the filter
device is coupled to an exterior surface of the second cannula.
18. A method comprising: advancing a cannula percutaneously;
enlarging a distal diameter of a filter device; injecting at least
one treatment agent into a tissue with at least one needle;
restraining matter with the filter device; contracting the distal
diameter of the filter device; and retracting the cannula.
19. The method of claim 18, wherein said injecting comprises
injecting the at least one treatment agent into a left ventricle,
and wherein said enlarging comprises enlarging the distal diameter
of the filter device at a position ranging from a carotid artery to
papillary muscles that are distal to an aortic valve.
20. The method of claim 19, wherein the position ranges from the
carotid artery to leaflets of the aortic valve.
21. The method of claim 18, wherein said enlarging comprises
compressing a helical spring of the filter device.
22. The method of claim 18, wherein said enlarging comprises
twisting a helical spring of the filter device.
23. The method of claim 18, further comprising aspirating material
concentrically around the at least one needle.
24. The method of claim 18, further comprising alternately flushing
a region including the at least one needle and aspirating the
region including the at least one needle.
25. The method of claim 18, further comprising: aspirating a
material proximate the at least one needle; and sensing a condition
selected from a pressure of the aspirated material and a flow rate
of the aspirated material.
26. The method of claim 18, further comprising aspirating a
material through at least one aspiration port through an exterior
surface of the filter device.
27. An apparatus comprising: a cannula to be percutaneously
advanced through a blood vessel, the cannula having a proximal
portion and a distal portion; at least one needle coupled to the
distal portion of the cannula; at least one lumen through the
cannula from the proximal portion to the at least one needle to
provide at least one therapeutic agent to the at least one needle;
at least one aspiration port proximate the at least one needle; and
at least one lumen through the cannula from the proximal portion to
the at least one aspiration port to convey suction provided at the
proximal portion of the cannula to the at least one aspiration
port.
28. The apparatus of claim 27, wherein the at least one aspiration
port comprises at least one aspiration port on a distal end face of
the cannula where the at least one needle is coupled.
29. The apparatus of claim 27, wherein the at least one aspiration
port comprises a plurality of aspiration ports distributed around
the at least one needle.
30. The apparatus of claim 29, wherein the plurality of aspiration
ports are distributed concentrically around the at least one needle
at a distal end face of the cannula where the at least one needle
is coupled.
31. The apparatus of claim 29, wherein the at least one aspiration
port comprises a plurality of aspiration ports distributed along a
distal segment of the cannula.
32. The apparatus of claim 27, wherein the at least one aspiration
port comprises an aspiration/flush port, and wherein the
aspiration/flush port is alternatively coupled with a source of
pressure to flow a fluid outwardly through the aspiration/flush
port and with a suction to draw a material inwardly through the
aspiration/flush port.
33. The apparatus of claim 27, further comprising at least one
sensor to sense at least one of pressure of an aspirated fluid and
flow rate of the aspirated fluid.
Description
BACKGROUND
[0001] 1. Field
[0002] Embodiments of the invention relate to medical devices, or
methods of using medical devices. In particular, embodiments of the
invention relate to a cannula having a needle and a filter device,
or methods of using a cannula having a needle and a filter
device.
[0003] 2. Background Information
[0004] In some cases, it is desirable to perform a local treatment
at a particular internal site within a patient, as opposed to a
systemic treatment. For example, this may be the case when a
concentration of one or more substances used to treat the internal
site cannot be effectively achieved by introduction of the
substance systemically or remotely from the site internal.
Moreover, the physician may want to treat the site, such as, for
example, a diseased portion of an organ or tissue, without treating
healthy portions of the organ or tissue.
[0005] The local treatment may involve a physician, surgeon, or
other practitioner, delivering one or more substances, such as one
or more pharmaceuticals or other treatment agents, to the internal
site. In order to achieve such local treatment of the internal
site, the practitioner may use one or more catheters, cannula, or
other medical devices to be inserted into a patient, in order to
navigate to the site and deliver the one or more substances to the
site.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0006] The invention may best be understood by referring to the
following description and accompanying drawings that are used to
illustrate embodiments of the invention. In the drawings:
[0007] FIG. 1 schematically illustrates an embodiment of a catheter
system that includes a cannula, at least one needle, and a filter
device.
[0008] FIG. 2A is a side view of a cannula and an embodiment of a
filter device including a helical spring shown with a contracted
diameter. In this embodiment the helical spring is capable of being
compressed to expand the diameter of the helical spring.
[0009] FIG. 2B is a side view of the cannula and the filter device
of FIG. 2A, in which the filter device has an expanded diameter as
a result of axial compression of the helical spring.
[0010] FIG. 3A is a side view of a cannula and another embodiment
of a filter device including a helical spring shown with a
contracted diameter. In this embodiment the helical spring is
capable of being twisted to expand the diameter of the helical
spring and the filter device.
[0011] FIG. 3B is a side view of the cannula and the filter device
of FIG. 3A, in which the filter device has an expanded diameter as
a result of twisting the helical spring.
[0012] FIG. 4 schematically illustrates an embodiment of the
placement of a distal portion of a catheter system in a heart
during an injection of one or more therapeutic agents into a left
ventricle.
[0013] FIG. 5 schematically illustrates an embodiment of a catheter
system that includes at least one needle and at least one
aspiration port proximate the at least one needle.
[0014] FIG. 6 is a front perspective view of a distal end portion
of a cannula illustrating a possible arrangement of a plurality of
aspiration ports distributed concentrically around a needle that is
extendable/retractable from the distal end of the cannula.
[0015] FIG. 7 is a side view illustrating an embodiment of a distal
end portion of a cannula having at least one needle and a plurality
of aspiration ports distributed along a distal length of the
cannula.
[0016] FIG. 8 is a cross-sectional view taken along a central axis
of an embodiment of a distal end portion of a cannula having at
least one needle coupled thereto and at least one aspiration and
flush (A/F) port.
[0017] FIG. 9 is a side view of a distal end portion of a cannula
including an embodiment of a filter device, in which there is at
least one aspiration port through an exterior surface of the filter
device.
[0018] FIG. 10 is a side view of an embodiment of a distal end
portion of a cannula having a lumen, at least one aspiration port,
and at least one sensor to sense a condition of an aspirated fluid
in the lumen.
[0019] FIG. 11 schematically illustrates an embodiment of a
catheter system that includes a first cannula having at least one
needle and a second cannula having a filter device, in which the
first cannula is inserted through the second cannula.
[0020] FIG. 12 is a flow diagram of an embodiment of a process of
using a filter device to restrain and optionally aspirate
particles.
DETAILED DESCRIPTION
[0021] In the following description, numerous specific details are
set forth. However, it is understood that embodiments of the
invention may be practiced without these specific details. In other
instances, well-known structures and techniques have not been shown
in detail in order not to obscure the understanding of this
description.
[0022] FIG. 1 schematically illustrates an embodiment of a catheter
system 100. The catheter system includes a cannula 102, at least
one needle 104, and a filter device 106.
[0023] The cannula 102 has a proximal end 108 and a distal end 109.
The cannula may be sized for and capable of being percutaneously
advanced through a blood vessel.
[0024] The catheter system also includes the at least one needle
104. The at least one needle is coupled to the distal end of the
cannula. The at least one needle may be used to inject one or more
therapeutic or treatment agents into a tissue. In some cases, the
catheter system may include a plurality of needles coupled to the
distal end thereof, such as, for example, to inject different
therapeutic agents. The catheter system includes a needle slider
110 to slide the at least one needle.
[0025] In some applications, a distal portion of the catheter
system having the at least one needle may be percutaneously
advanced through a blood vessel and used to inject a therapeutic
agent into a tissue, such as, for example, a tissue of the heart.
One challenge with such injections is the potential for stroke or
embolism under certain conditions. For some injectable therapeutic
agents, the potential for stroke or embolism may be especially
great in the event of non-engagement or disengagement of the one or
more needles. At least for certain therapeutic agents, if the
therapeutic agent leaks out of the tissue or site of injection, or
is delivered outside of the tissue or site of intended injection,
such as by an insufficiently engaged needle, there may be a risk of
stroke or embolic hazard. Certain such therapeutic agents may cause
thrombus or blood clots that may pose an embolic risk. Other
therapeutic agents may gel, coagulate, or otherwise aggregate and
thereby pose an embolic risk.
[0026] Referring again to the illustration, the catheter system
also includes the filter device 106. The filter device is coupled
at a position proximal to the at least one needle. The filter
device has a distal portion that is operable to have a first
diameter under a first condition and a second, different, larger
diameter, under a second condition.
[0027] Advantageously, including the filter device may help to
restrain thrombus, blood clots, injectate, gelled or otherwise
aggregated injectate, or other such matter larger than blood cells.
Filtering or restraining this matter before it reaches the brain or
other peripheral tissues may help to avoid, or at least reduce, the
risk of stroke or embolism.
[0028] Various filter device designs are contemplated.
[0029] FIG. 2A is a side view of a cannula 202 and an embodiment of
a filter device 206 including a helical spring 212 shown with a
contracted diameter (D1), in this embodiment the helical spring is
capable of being compressed to expand the diameter of the helical
spring.
[0030] The cannula has a distal end or portion 209 and a proximal
end or portion 208. The filter device is coupled to an exterior
surface of the cannula at the distal portion of the cannula or
toward the distal end. Typically, the filter device is coupled
within about 25 cm, often within about 15 cm, of the distal end of
the cannula, although this is not required.
[0031] The filter device has a frame portion including the helical
spring 212. By way of example, the helical spring may include a
forged material, a molded material, or a wound material. Often, the
helical spring may include or be made of a metal. For example,
various metals used in stents are suitable. The term metal is
intended to include both pure metals and alloys. Alternatively, the
helical spring may be made of a plastic, such as of the types used
in stents or like medical devices. If desired, the helical spring
may be made of, or include, a shape memory metal or material. A
representative helical spring is shown, although other helical
springs, such as having different numbers of coils, may be used
instead. Notice that in the starting condition the helical spring
and the filter device have a first diameter (D1) and a first length
(L1) along the axis of the cannula.
[0032] A filtration material 214 is coupled to the helical spring
or frame portion of the filter device. A portion of the filtration
material may be coupled axially around the exterior surface of the
cannula. Examples of suitable couplings include, but are not
limited to, laser bonding, adhesive bonding, thermal bonding, and
mechanical restriction (for example weaving, tying, or sewing the
filtration material to the frame portion).
[0033] The filtration material has, or is pierced with, a plurality
of openings. The openings may allow blood to flow through them,
while restraining larger particles or materials. By way of example,
the filter material may include, or be made of, natural or
synthetic materials, plastics, polymer mesh material,
polytetrafluoroethylene, stainless steel, PEBAX 91 (a biocompatible
polymer, such as a polyether block amide resin, sold under the
trademark PEBAX.TM. of ATOCHEM CORPORATION, PUTEAUX, FRANCE). Some
such materials may be spun or weaved together and fixed to the
frame by knots, ties, adhesives, or the like. Another suitable
material is a rubber or other material used for a balloon that has
holes formed therein. These are just a few examples. Other embolic
protection material and filtration materials are also suitable.
[0034] The helical spring has a distal end or portion 216 and a
proximal end or portion 218. The distal end or portion of the
helical spring is coupled to the exterior surface of the cannula at
a fixed position. The proximal end or portion of the helical spring
is coupled to a distal end or portion of a shaft 220. The couplings
may be achieved by laser bonding, adhesive bonding, heat bonding,
welding, mechanical connections, or other bonding or coupling
techniques.
[0035] The shaft may be an elongated, slender, generally
cylindrical mandrel, tendon, wire, bar, rod, or like member. By way
of example, the shaft may be made of metal or rigid plastic. The
shaft has a proximal end or portion 222 that is at or near the
proximal end or portion of the cannula. It is not required that the
shaft go all the way to the end of the cannula, as shown in the
illustration, as long as the proximal end of the shaft is
sufficiently accessible to a practitioner to allow the practitioner
to push or otherwise actuate the shaft via its proximal end or
portion.
[0036] A practitioner may press on the shaft in the distal
direction shown by arrow 224. The shaft may represent or serve as a
plunger that is operable to slide along the axis of the cannula in
the distal direction. This may cause the shaft to exert a force on
and compress the helical spring to enlarge the diameter of the
helical spring and therefore the filter device.
[0037] FIG. 2B is a side view of the cannula 202 and the filter
device 206 of FIG. 2A, in which the filter device has an expanded
diameter (D2) as a result of axial compression of the helical
spring 212 as a result of movement of the shaft 220 in the distal
direction 224 by a distance (d). In this condition the filter
device has a second, greater diameter (D2) and a second, shorter
length (L2). The greater diameter (D2) may approximate an inner
diameter of a blood vessel 226 at a region of interest. The
different diameters of the filter device are a result of different
conditions that include different amounts of compression of the
helical spring. Notice also that the filter device has a generally
tubular shape in the expanded diameter condition.
[0038] In embodiments, the expanded diameter of the helical spring
and the filter device may be approximately equivalent to an inner
diameter of a blood vessel at a region of interest proximal to an
injection site. Advantageously, the helical spring may be
compressed by different amounts to achieve these different
diameters. If desired, latches or locks may be provided to hold the
shaft in different positions to keep the diameter of the filter
device from changing unintentionally. In this way, substantially
all of the blood flowing through the blood vessel may pass through
the filter. The filter device may not be a hollow cylinder, but
rather may have filter material that is transverse to the direction
of blood flow and that substantially spans the entire cross
sectional area available for blood flow. By way of example, the
filter material may be coupled axially around the cannula, such as,
for example, at one or both of the ends of the filter device. The
filter device may be used restrain thrombus or other unwanted
particles or material having a size greater than an average size of
blood cells. For example, a typical red blood cell has a size of
approximately 7 micrometers in diameter, and a typical white blood
cell has a size of between approximately 7 and 15 micrometers in
diameter.
[0039] FIG. 3A is a side view of a cannula 302 and another
embodiment of a filter device 306 including a helical spring 312
shown with a contracted diameter (D1), in this embodiment the
helical spring is capable of being twisted to expand the diameter
of the helical spring and the filter device.
[0040] This embodiment has features similar to those of the
embodiment shown and described for FIGS. 2A-2B. For brevity, all of
the similar features will not be repeated. Rather, the discussion
will tend to emphasize the new or different features shown in FIGS.
3A-3B.
[0041] As before, the filter device is coupled to an exterior
surface of the cannula at a distal portion of the cannula. The
filter device has a frame portion including the helical spring 312
and a filtration material 314 having a plurality of openings
coupled to the helical spring. A distal end or 316 of the helical
spring is coupled to the exterior surface of the cannula at a fixed
position. A proximal end or portion 318 of the helical spring is
coupled to a distal end or portion of a shaft 320. The shaft has a
proximal end or portion 322 that is at or near the proximal end or
portion 308 of the cannula. The helical spring and the filter
device have a first diameter (D1) and a first length (L1) along the
axis of the cannula.
[0042] Now, in this embodiment, the helical spring may include a
torsion spring. The shaft may be operable to rotate or otherwise
turn about the cannula to twist the helical spring. A practitioner
may turn the shaft about the cannula as shown by arrow 324. This
may cause the shaft to exert a force on the proximal end of the
helical spring that is attached to the shaft. This may may result
in twisting of the helical spring, which may enlarge the diameter
of the helical spring and therefore the filter device.
[0043] If the rotation or twisting is in the same direction as the
coils are wound (tightening of the spring), then the rotation or
twisting of the helical spring may cause a decrease in the diameter
of the helical spring and filter device. If the rotation or
twisting is in the opposite direction as the coils are wound
(loosening of the spring), then the rotation or twisting of the
helical spring may cause an increase in the diameter of the helical
spring and filter device. Advantageously, the helical spring may be
twisted by different amounts to achieve different diameters.
[0044] FIG. 3B is a side view of the cannula 302 and the filter
device 306 of FIG. 3A, in which the filter device has an expanded
diameter (D2) as a result of twisting the helical spring 312 as a
result of turning the shaft 320 about the cannula. In this
condition the filter device has a second, greater diameter (D2) and
a second, shorter length (L2). The different diameters are a result
of different conditions that include different amounts of twisting
of the helical spring. Notice also that the filter device has a
generally tubular shape in the expanded diameter condition.
[0045] Other filter device designs are also suitable. For example,
other suitable filter device designs are disclosed in U.S. Patent
Application Publication 2005/0015048 (hereinafter "the '048
publication"), entirely incorporated herein by reference. In brief,
FIGS. 7-18 of this publication show cannula having filter devices.
FIG. 19 of this publication shows a process for using a filter
device to restrain and aspirate particles.
[0046] As one example, FIGS. 7-10 of the '048 publication show a
filter device and a sheath. The filter device includes a frame
portion and a filter material having or pierced by openings that is
coupled to the frame portion. The filter device has a proximal end
or portion axially coupled to a cannula. FIG. 7 shows the filter
device within a sheath. The sheath restrains a distal diameter of
the filter device. FIG. 9 shows that the sheath may be retracted in
a proximal direction to allow the distal diameter of the filter
device to expand. In one aspect, the expanded distal diameter may
approximate an inner diameter of a blood vessel or coronary sinus.
In various aspects, the filter device may include a shape memory
material, self-expanding material, or may expand due to pressure
from fluid flow. In this condition, the filter device has a
generally conical shape. The sheath may be advanced in a distal
direction to at least partially contract the distal diameter of the
filter device, such as to allow the cannula having the filter
device to be retracted percutaneously.
[0047] As another example, FIGS. 11-13 of the '048 publication show
a cannula, a filter device, and balloons coupled to the filter
device and/or the cannula. FIG. 11 shows the filter device with the
balloons before they are inflated. In this condition, the distal
portion of the filter device has a first, lesser diameter. FIG. 12
shows that the balloons may be inflated to expand the diameter of
the distal portion of the filter device. The filter device may
optionally include protruding barbs or anchors to engage tissue to
help hold the filter device in place, or else may have
non-traumatic tips. Again, in this condition, the filter device has
a generally conical shape. FIG. 13 shows that the balloons may be
deflated to at least partially contract the distal diameter of the
filter device. The filter device may potentially include a
self-contracting material or shape memory material.
[0048] As yet another example, FIGS. 14-16 of the '048 publication
show a cannula, a filter device, and tendons that extend through
the cannula. The tendons are attached to a distal portion of the
filter device. FIG. 14 shows the filter device with a contracted
distal diameter. FIG. 15 shows that the tendons may be used to
expand the diameter of the distal portion of the filter device.
FIG. 16 shows that the tendons may be used to at least partially
contract the distal diameter of the filter device.
[0049] For brevity, just a few of the details of the previously
disclosed filter devices have been repeated herein. Further
details, if desired, are available in the '048 publication, which
has been incorporated herein by reference. Any of these
aforementioned filter devices may potentially be used in the
medical devices disclosed herein.
[0050] Now, in one or more embodiments, a catheter system, such as
that shown in FIG. 1, may be an intra-myocardial needle injection
catheter system that is used to inject one or more treatment agents
into a tissue of the heart. For example, in an embodiment, a
catheter system may be used to inject one or more treatment agents
into the left ventricle of the heart.
[0051] FIG. 4 schematically illustrates an embodiment of the
placement of a distal portion of a catheter or cannula system 400
in a heart 430 during an injection of one or more therapeutic
agents into a left ventricle 432.
[0052] The cannula system 400 may be introduced to the patient
vasculature through a femoral artery access point (not shown). The
cannula system may be advanced up the aorta, around the aortic
arch, passed through the ascending aorta 436, passed through the
aortic valve 434, and into the left ventricle 432. Once inside the
left ventricle, the cannula may be manipulated by the operator,
such as by applying torque, translating the cannula system, and
deflecting the distal tip of the cannula system to achieve
tip-to-wall contact at the desired location on the left ventricular
wall.
[0053] At least one needle 404 coupled to a distal end of the
cannula is positioned against the wall of the left ventricle. The
at least one needle is inserted into the myocardial tissue of the
left ventricle to deliver one or more therapeutic agents therein.
By way of example, the therapeutic agents may include stem cells,
genes, or growth factors, although the scope of the invention is
not limited to the delivery of just these types of therapeutic
agents.
[0054] In the illustration, the filter device 406 is positioned
just proximally of the aortic valve 434 in the ascending aorta 436.
The illustrated filter device has an expanded diameter that
provides full apposition to the aortic wall so that all of the
blood passing through the aorta is filtered by the filter device.
By way of example, the inner diameter of the aorta for an adult
typically ranges from about 1.5 centimeters (cm) to about 2 cm.
[0055] However, the scope of the invention is not limited to just
this particular position for the filter device. In embodiments of
the invention, if the at least one needle were positioned to inject
a treatment agent into the left ventricle of a representative
patient for which the catheter system was designed to treat, then
the filter device would have a position ranging from a carotid
artery proximal to the aorta to papillary muscles 438 that are
distal to the aortic valve 434. In an embodiment of the invention,
the filter device would have a position ranging from the carotid
artery to the leaflets of the aortic valve. It is in these
positions that the diameter of the filter device would be expanded
or enlarged to approximately equal that of the surrounding blood
vessel or anatomical features. Typically the filter device should
be positioned away from the leaflets of the aortic valve so as not
to substantially interfere with their operation. As used herein,
designed to treat a representative patient means that the design of
the catheter system assumes something about the size of the patient
it is intended to treat. For example, the representative patient
may refer to a typical or average sized adult.
[0056] In other embodiments, the catheter system may be used to
inject one or more treatment agents into the right ventricle of the
heart. In such embodiments, if the at least one needle were
positioned to inject a treatment agent into the right ventricle of
a representative patient for which the catheter system was designed
to treat, then the filter device may be positioned appropriately to
occlude the pulmonary artery outflow tract.
[0057] It is not required that a needle injection catheter system
include a filter device. In one or more other embodiments, a needle
injection catheter system may include at least one hole or other
aspiration port to aspirate or remove thrombus, stray injectate, or
other unwanted material.
[0058] FIG. 5 schematically illustrates an embodiment of a catheter
system 500. The catheter system includes at least one needle 504
and at least one hole or other aspiration port 540 proximate the at
least one needle.
[0059] The catheter system includes a cannula 502. The cannula has
an exterior surface, a proximal end 508, and a distal end 509. As
previously discussed, the cannula may be percutaneously advanced
through a blood vessel.
[0060] The catheter system also includes the at least one needle
504 coupled to the distal end 509 of the cannula. The at least one
needle may be used to inject one or more therapeutic agents into
tissue. In some cases, the catheter system may include a plurality
of needles coupled to the distal end thereof, such as, for example,
to inject different therapeutic agents. The catheter system
includes a needle slider 510 to slide the at least one needle.
[0061] The catheter system also includes the at least one hole or
other aspiration port 540. The at least one hole or other
aspiration port is proximate the at least one needle. As used
herein, the at least one aspiration port is proximate the at least
one needle if they are within 10 millimeters (mm) and they are very
proximate if they are within 3 mm.
[0062] As shown, the at least one aspiration port may be on a
distal end face 542 of the cannula where the at least one needle is
coupled. The distal end face often has a diameter on the order of
10 French or less, and accordingly the aspiration port is generally
within 2 mm or less from the needle. Advantageously, placing the at
least one aspiration port on the distal end face very proximate the
needle may help to remove stray injectate not properly injected
into the tissue, injectate that leaks out of the tissue, and/or
thrombus resulting from the injection. In one or more embodiments,
the at least one aspiration port is within 3 mm or less from the
needle. In various embodiments, the aspiration port may have a
diameter or other cross-sectional dimension typically ranging from
about 20 to 1000 micrometers, often ranging from about 30 to 500
micrometers, sometimes ranging from about 50 to 200
micrometers.
[0063] A lumen 544 runs through the cannula from the at least one
aspiration port to the proximal portion of the cannula. A vacuum,
syringe, or other suction device 546 may be coupled with the
proximal portion of the cannula. The suction device may be
permanently coupled, or alternatively the cannula may have a
connector to allow the suction device to be coupled and decoupled.
The lumen may convey the suction provided by the suction device at
the proximal portion of the cannula to the at least one aspiration
port. The suction may be used to aspirate or remove unwanted
materials.
[0064] Advantageously, the at least one aspiration port may help to
aspirate or remove thrombus, blood clots, injectate, gelled or
otherwise aggregated injectate, or other such matter. This may help
to reduce the likelihood of stroke or embolism.
[0065] Another potential benefit of locating the at least one
aspiration port on the distal end face of the cannula where the at
least one needle is coupled is the potential that the suction
provided through the at least one aspiration port may help to
improve the injection of the needle and the therapeutic agent into
the tissue. The suction may help to encourage good coupling or
contact between the at least one needle and the tissue. Some
tissues, such as, for example, myocardial or ventricular tissues,
may expand, contract, or otherwise move, such as due to the cardiac
cycle. The suction provided by the at least one aspiration port may
help to encourage good coupling or contact between the needle and
the tissue where the needle is injected. This may help to promote
injection of the therapeutic agent at a more consistent and
predictable needle engagement depth in the tissue especially when
the tissue is moving. This may also help to reduce unwanted
perforation of the myocardial wall or other tissue and the
possibility of subsequent pericardial effusion or tamponade.
[0066] The illustrated catheter system does not have a filter
device in order to emphasize that aspiration ports and filter
devices may optionally be used separately. However, other
embodiments are contemplated in which a needle injection catheter
system or cannula includes both a filter device and at least one
aspiration port (for example see FIG. 11).
[0067] FIG. 6 is a front perspective view of a distal end portion
of a cannula 609 illustrating a possible arrangement of a plurality
of holes or other aspiration ports 640 distributed concentrically
around a needle 604 coupled with the distal end of the cannula.
[0068] The plurality of aspiration ports are concentrically
distributed around the at least one needle. The plurality of
aspiration ports reside at or on a distal end face 642 of the
cannula or catheter where the at least one needle is coupled.
Advantageously, both of these features may help to improve the
aspiration or removal of unwanted material originating from, or as
a result of, the needle.
[0069] In the illustration, three aspiration ports are shown,
although in alternate embodiments, fewer or more aspiration ports
may optionally be used. In the illustration, circular holes or
aspiration ports are shown, although in alternate embodiments
square, oval, rectangular, c-shaped, concentric, or other shaped
openings may optionally be used.
[0070] FIG. 7 is a side view illustrating an embodiment of a distal
end portion of a cannula 709 having at least one needle 704 and a
plurality of holes or other aspiration ports 740 distributed along
a distal length of the cannula.
[0071] As shown, the plurality of aspiration ports may be
concentrically distributed around the exterior surface of a distal
length of the cannula. The aspiration ports may begin at, adjacent,
or at least near, the distal end of the cannula. The aspiration
ports may extend a distance in the proximal direction away from the
distal end of the cannula. The scope of the invention is not
limited to any known distance, although typically the distance is
less than 10 cm, often less than 3 cm, sometimes less than 2 cm,
sometimes less than 1 cm.
[0072] The illustration shows a particular number of ports,
although fewer or more ports may optionally be used. Likewise, the
illustration shows a particular arrangement of the ports, although
other arrangements are also contemplated. If desired, the number of
ports, or the number of ports per unit length of the cannula, may
optionally increase with increasing proximity to the distal end of
the cannula. In the illustration, circular ports are shown,
although in alternate embodiments square, oval, rectangular, or
other shaped openings may optionally be used.
[0073] In some embodiments, an annular or at least partially
enclosed space may exist between a portion of a needle and a
portion of a distal end of a cannula where the needle is coupled.
One potential challenge is that blood may enter this annular or at
least partially enclosed space and may tend to clot, which may tend
to pose a potential embolic risk.
[0074] FIG. 8 is a cross-sectional view taken along a central axis
of an embodiment of a distal end portion of a cannula 809 having at
least one needle 804 coupled thereto and at least one aspiration
and flush (A/F) port 840.
[0075] The cannula has the at least one A/F port 840. The at least
one A/F port is proximate the at least one needle. As used herein,
the at least one aspiration port is proximate the at least one
needle if they are within 5 mm. The cannula also has at least one
lumen 844 running through it from the at least one A/F port to a
proximal portion of the cannula (at left in the illustration).
[0076] The at least one lumen is configured to alternately aspirate
or draw a material inwardly through the at least one hole or other
A/F port, and flush or flow a fluid outwardly through the at least
one hole or other A/F port. This may be achieved in different ways.
In one example embodiment, the at least one lumen may include a
single lumen coupled to both a suction device, such as a syringe,
to provide suction for aspiration and alternately a pressure
increasing device, such as a syringe or pump, to provide pressure
to flow a flushing fluid. In another example embodiment, the at
least one lumen may include a first lumen coupled to a suction
device to provide suction for aspiration and a second lumen coupled
to a pressure increasing device to alternately provide pressure to
flow a flushing fluid, where both of the lumen are coupled to the
at least one A/F port.
[0077] As shown, in one or more embodiments, an annular or at least
partially enclosed space 848 may exist between a portion of the
needle and a portion of the distal end of the cannula. As
previously mentioned, one potential challenge is that blood may
enter this annular or at least partially enclosed space and may
tend to clot. A blood clot formed in this space may tend to inhibit
aspiration and/or may dislodge and pose an embolic hazard.
[0078] As shown, in one or more embodiments, the A/F port may be
located or positioned in this annular or at least partially
enclosed space and/or be located or positioned elsewhere but
located or positioned to flush or flow a fluid outwardly from the
lumen into this annular or partially enclosed space.
Advantageously, such flushing of this annular or at least partially
enclosed space may help to reduce entry of blood into this annular
or at least partially enclosed space and/or clotting of blood in
this annular or at least partially enclosed space. This may help to
promote good aspiration and may help to lessen the embolic
hazard.
[0079] In one or more embodiments, the flushing fluid may include a
heparinized saline solution, other anticoagulant solution, or other
anticlotting solution. Advantageously, use of such an anticoagulant
or anticlotting solution may further help to prevent coagulation or
clotting of blood in the annular or at least partially enclosed
space. Alternatively, simple saline solutions or other suitable
flushing solutions may optionally be used.
[0080] In an alternate embodiment, a hole or port similar to the
A/F port may be used for either aspiration or flush, but not both
aspiration and flush.
[0081] FIG. 9 is a side view of a distal end portion of a cannula
909 including an embodiment of a filter device 906, in which there
is at least one hole or other aspiration port 940 through an
exterior surface of the filter device. In some cases there may be a
plurality of aspiration ports through the filter device.
[0082] Note that the illustrated cannula 909 and the filter device
906 are similar to those of FIG. 9 of the '048 publication.
Alternatively, other filter device designs as described herein may
be used.
[0083] The cannula includes a lumen 944. The lumen runs through the
cannula from a proximal portion or end of the cannula to a distal
end or portion of the cannula. The lumen is in fluid communication
with the at least one aspiration port through the exterior surface
of the filter device.
[0084] There are different ways of providing fluid communication
between the lumen of the cannula and the at least one aspiration
port through the filter device. In the illustration, an expanded
view of a portion of the filter device having the at least one
aspiration port is used to show one approach. As shown, in one or
more embodiments, the portion of the filter device having the at
least one aspiration port may include a slender metal tube or
tubular structure 950, such as, for example, a hypotube. The
tubular structure may have at least one hole, representing at least
one aspiration port, through an outer wall thereof leading to an
inside of the tubular structure. The inside of the tubular
structure may serve as an aspiration lumen that is integrated with
the filter device. A proximal end of the tubular structure may be
in fluidic communication or coupling with the lumen of the cannula.
Alternatively, other lumens, conduits, or channels may couple the
at least one aspiration port through the filter device with the
lumen of the cannula.
[0085] It is not required to directly couple the lumen of the
cannula to the tubular structure, lumen, channel, or conduit of the
filter device. As shown, the filter device may optionally have a
manifold 952. The manifold may fluidically couple the lumen of the
cannula with tubular structures, lumen, conduits, or channels of
the filter device leading to the at least one aspiration port or
ports. In one aspect, the manifold may have an inlet coupled with
the lumen of the cannula and a plurality of outlets each coupled
with a different tubular structure, lumen, conduit, or channel of
the filter device to provide suction to a plurality of aspiration
ports dispersed at different locations on the filter device.
[0086] The lumen of the cannula may convey or provide suction
provided at the proximal portion or end of the cannula to the at
least one hole or other aspiration port through the filter device.
This suction may be used to aspirate or withdraw thrombus, or other
unwanted particles or materials through the at least one aspiration
port through the filter device. Accordingly, the filter device may
incorporate a suction or aspiration mechanism or means.
Advantageously, integrating the at least one aspiration port
direction with the filter device may help to promote direct
aspiration or removal of material restrained by the filter
device.
[0087] FIG. 10 is a side view of an embodiment of a distal end
portion of a cannula 1009 having a lumen 1044, at least one hole or
other aspiration port 1040, and at least one sensor 1054 to sense a
condition of an aspirated fluid in the lumen.
[0088] The cannula, the lumen, and the aspiration port may be
substantially as previously shown and described.
[0089] The sensor or sensing device may be in the lumen, at least
partially in the lumen, or adjacent to the lumen. The sensor may
sense a condition of a fluid in the lumen. By way of example, the
at least one sensor may sense at least one of a pressure of a fluid
in the lumen and a flowrate of the fluid in the lumen.
[0090] In one aspect, the sensor may include a MEMS-based pressure
sensor. MEMS-based pressure sensors are available from various
sources, such as, for example, from Freescale Semiconductor, of
Austin, Tex. In another aspect, the sensor may include a
piezoelectric pressures sensor. In yet another aspect, the sensor
may include a MEMS flow sensor. MEMS flow sensors are known in the
art, such as, for example, from U.S. Pat. No. 7,337,678.
[0091] The sensor may help to allow confirmation of suction,
vacuum, sub-atmospheric pressure, or flow of fluid in the lumen.
Advantageously, this may help to allow confirmation that the
aspiration is working properly.
[0092] FIGS. 1 and 5 show that needled catheter systems may either
have filter devices or aspiration ports. However, it is also
possible for a needled catheter system to have both a filter device
and at least one aspiration port distal to the filter device. For
example, the filter device 106 of FIG. 1 may be included in the
catheter system 500 of FIG. 5 which has the at least one aspiration
port 540. One potential advantage is that the aspiration port may
help to aspirate additional material and/or material restrained by
the filter device that becomes dislodged, such as, for example,
when the filter device is contracted or moved. In addition, the
apparatus disclosed herein may optionally incorporate other
features, such as, for example, the occlusion devices, or other
features as described in the '048 publication. By way of example,
the occlusion devices may include balloons, tapered balloons, ePTFE
balloons, as described in the '048 publication.
[0093] Additionally, instead of a single catheter or cannula, two
or more catheters or cannulas may optionally be used together. For
example, a guide catheter or cannula and a delivery catheter or
cannula may optionally be used together.
[0094] FIG. 11 is a cross sectional view of an embodiment of a
distal end portion of a catheter system 1109 that includes a distal
end portion of a first cannula 1109 having at least one needle 1104
coupled thereto, and a distal end portion of a second cannula 1156
having a filter device 1106 coupled thereto. In the illustration,
the first cannula is inserted through the second cannula, although
the cannula may be otherwise coupled together.
[0095] The at least one needle 1104 is coupled to the distal end
portion of the first cannula 1109. In one or more embodiments, the
first cannula may include a delivery catheter or cannula. As shown,
at least one aspiration port 1140 may be coupled to the first
cannula proximate the at least one needle. A lumen 1144 through the
first cannula may provide suction to the at least one aspiration
port.
[0096] The filter device 1106 is coupled at a position proximal to
the at least one needle. The filter device is coupled to an
exterior surface of the distal end portion of the second catheter
or cannula 1156. In one or more embodiments, the second cannula may
include a guide catheter or cannula. The filter device has a distal
portion that is operable to have a first diameter under a first
condition and a second, different diameter under a second
condition.
[0097] Notice that the filter device and the at least one
aspiration port reside on or otherwise correspond to different
cannulas or catheters. One potential advantage of coupling the
filter device to the second cannula (e.g., a guide catheter or
cannula), and coupling the at least one aspiration port to the
first cannula (e.g., the delivery catheter or cannula), is that
this configuration may allow improved movement or positioning of
the needle relative to the intended injection site without having
to move the filter device out of place.
[0098] Kits including multiple uncoupled or unassembled cannula are
also contemplated. One of the cannula may have at least one needle
coupled to a distal end thereof, and potentially at least one
aspiration port, as described elsewhere herein. Another of the
cannula may have a filter device coupled thereto as described
elsewhere herein. In one aspect, multiple filters of different
sizes, constructions, or actuation mechanism may optionally be
provided. In one aspect, a suction device may optionally be
included to provide suction to an aspiration port. The kits may
optionally include instructions, such as instructions on how to
assemble the components of the kits and/or on how to use the
assembled components, such as how to use the filter device and/or
the aspiration port. The instructions may be written instructions
on paper or instructions stored on a compact disk or other
machine-readable medium. The kits may be sealed in a manufacturer's
sealed package or packaging.
[0099] FIG. 12 is a flow diagram of an embodiment of a process 1260
of using a filter device to restrain and optionally aspirate
particles.
[0100] At block 1262, at least one cannula, such as, for example,
cannula 102, may be advanced percutaneously through a blood vessel.
The cannula may have a proximal end and a distal end. At least one
needle may be coupled to the distal end of the at least one
cannula. The filter device may be coupled to the at least one
cannula at a position proximal to the at least one needle. It is
the distal end that is advanced percutaneously through the blood
vessel. In one aspect, the distal end of the cannula may be
advanced via a retrograde advancement, such as by being pushed up
or down a blood vessel (e.g., such as a blood vein or artery)
against or with a flow of blood. Specifically, the cannula may be
advanced, such as from one blood vessel into a smaller blood vessel
to provide retrograde infusion treatment, to a region of interest
such as a region in a coronary sinus, left or right ventricle, or
other portion of a heart of a subject.
[0101] At block 1264, a distal diameter, or other axial
cross-sectional dimension, of a filter device may be enlarged. This
is generally performed when the distal end of the cannula is near
the desired location. The filter device may have a distal portion
that is operable to have, or capable of having, a first diameter
under a first condition and a second, different diameter under a
second condition. By way of example, in embodiments, the
enlargement may include compressing a helical spring of the filter
device, or twisting a helical spring of the filter device, although
this is not required. The enlarged diameter or dimension may be
approximately equivalent to an inner diameter of a blood vessel, or
other cross-section available for blood flow, in order to filter
substantially all of the blood flowing through this
cross-section.
[0102] At block 1266, at least one treatment agent may be injected
into an internal tissue of a patient with at least one needle. This
is commonly performed after the enlargement of the distal diameter,
although this is not required. The distal diameter may
alternatively be enlarged concurrently with or soon after the
injection. In one embodiment, the at least one treatment agent may
be injected into a left ventricle, and the distal diameter of the
filter device may be enlarged at a position ranging from a carotid
artery to papillary muscles that are distal to an aortic valve, or
ranging from the carotid artery to leaflets of the aortic valve.
However, the scope of the invention is not limited to injection
into the left ventricle.
[0103] At block 1268, thrombus, gel, aggregated injectate, pieces
of tissue, particles, or other material may be restrained with the
filter device. In one aspect, the material restrained may have a
size greater than an average size of blood cells contained in blood
flowing through the filter device.
[0104] At block 1270, the restrained particles may optionally be
aspirated. However, this is optional, since it is not required that
both a filter device and aspiration be used together. If the
aspiration is desired, in embodiments, the aspiration may be
achieved through at least one aspiration port proximate the at
least one needle. In one or more embodiments, the aspiration may
include aspirating material concentrically around the at least one
needle. In one or more embodiments, the aspiration may include
aspirating a material through at least one aspiration port through
an exterior surface of the filter device. In one or more
embodiments, the aspiration may include alternately flushing a
region including the at least one needle and aspirating the region
including the at least one needle. In one or more embodiments, in
addition to the aspiration, a condition of the aspirated material
may be sensed with a sensor. By way of example, the condition may
include a pressure of the aspirated material and a flowrate of the
aspirated material.
[0105] At block 1272, the distal diameter of the filter device may
typically be contracted. This means at least partially contracted,
since it is not required that the distal diameter be fully
contracted.
[0106] At block 1274, the cannula and the filter device may be
retracted. For example, the cannula may be retracted or withdrawn
percutaneously back through the blood vessel through which it was
previously advanced and out of the patient.
[0107] A particular method has been described to illustrate certain
concepts. Operations may optionally be added to and/or removed from
the methods. For example, aspiration and/or contraction of the
distal diameter may optionally be removed. The operations of the
methods may also often optionally be performed in different order.
For example, enlargement may be after injection. Many modifications
and adaptations may be made to the methods and are
contemplated.
[0108] In the above description and the claims below, the terms
"coupled" and "connected," along with their derivatives, may be
used. It should be understood that these terms are not intended as
synonyms for each other. Rather, in particular embodiments,
"connected" may be used to indicate that two or more elements are
in direct physical or electrical contact with each other. "Coupled"
may mean that two or more elements are in direct physical or
electrical contact. However, "coupled" may also mean that two or
more elements are not in direct contact with each other, but yet
still co-operate or interact with each other, such as through one
or more intervening elements.
[0109] In the description above, for the purposes of explanation,
numerous specific details have been set forth in order to provide a
thorough understanding of the embodiments of the invention. It will
be apparent however, to one skilled in the art, that one or more
other embodiments may be practiced without some of these specific
details. The particular embodiments described are not provided to
limit the invention but to illustrate it. The scope of the
invention is not to be determined by the specific examples provided
above but only by the claims below. In other instances, well-known
structures, devices, and operations have been shown in block
diagram form or without detail in order to avoid obscuring the
understanding of the description.
[0110] It will also be appreciated, by one skilled in the art, that
modifications may be made to the embodiments disclosed herein, such
as, for example, to the sizes, shapes, configurations, forms,
functions, materials, and manner of operation, and assembly and
use, of the components of the embodiments. All equivalent
relationships to those illustrated in the drawings and described in
the specification are encompassed within embodiments of the
invention.
[0111] For simplicity and clarity of illustration, elements
illustrated in the figures have not necessarily been drawn to
scale. For example, the dimensions of some of the elements are
exaggerated relative to other elements for clarity. Further, where
considered appropriate, reference numerals or terminal portions of
reference numerals have been repeated among the figures to indicate
corresponding or analogous elements, which may optionally have
similar characteristics.
[0112] It should also be appreciated that reference throughout this
specification to "one embodiment", "an embodiment", or "one or more
embodiments", for example, means that a particular feature may be
included in the practice of the invention. Similarly, it should be
appreciated that in the description various features are sometimes
grouped together in a single embodiment, Figure, or description
thereof for the purpose of streamlining the disclosure and aiding
in the understanding of various inventive aspects. This method of
disclosure, however, is not to be interpreted as reflecting an
intention that the invention requires more features than are
expressly recited in each claim. Rather, as the following claims
reflect, inventive aspects may lie in less than all features of a
single disclosed embodiment. Thus, the claims following the
Detailed Description are hereby expressly incorporated into this
Detailed Description, with each claim standing on its own as a
separate embodiment of the invention.
* * * * *